The following is an English translation of a German paper on Hoecsht AG's
position regarding the importation of RU486 into any country.
It describes the mechanism by which RU486 works, some of the clinical
experience, and then, the most maddening part, they try to set the
moral/ethical framework for the debate by implying anyone who might be
against abortion is primitive and simplistic.
Behind the veneer of courtesy is a very strong message that they don't
care what pro- life concerns are. If there is a legal framework set in a
country who would receive the drug, then they'll sell it. Also, their
company policy which is explained below, claims to require a cultural
consensus in the country before it will bring it to that country, however,
that is certainly not the case in the US, but they did it anyway. They
are groping for justifications and policies to rationalize the production
and sale of RU486.
This is a long piece, but worth reading as it's from the "source". It's
also worth reading in order to learn what the real attitude of this
company is.
Landon
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Translation of the third edition of the German brochure
"Der medikamentose Schwangerschaftsabbruch mit Mifepriston (RU 486) und
Prostaglandin"
N.B. Please note that graphics printed on page 6 of the original brochure
are not included in the translated text.
DRUG INDUCED TERMINATION OF PREGNANCY WITH MIFEPRISTONE (RU 486) AND
PROSTIGLANDIN
Information from Hoechst AG
Pharmaceuticals Division, Health Policy Department
Third, expanded edition: July 1992
This publication, now presented in a revised edition, was published for
the first time in May 1991 and updated in October 1991. With it, HDECHST
aims to inform the general public in Germany and abroad, as well as our
shareholders, customers, business partners and staff, about drug-induced
termination of pregnancy with mifepristone, and to provide an insight into
the complex issues that have led to company policy decisions.
In the past year, the information provided by Hoechst has noticeably
influenced the intended communicative process both in- and outside the
company.
Conversely, the realizations and results obtained from numerous
discussions with representatives of various social groups from Germany and
abroad have been included in the revised edition.
The compilation of these experiences will hopefully serve to promote the
discussion started on the existential question of man's being.
HOECHST thanks all those who have participated in the discussion to date
and not least those who view this publication as an invitation to an open
dialogue with HOECHST.
TABLE OF CONTENTS
Discovery and properties of mifepristone (RU 486)
The use of mifepristone
Responsibility of the manufacturer
The legal situation in the U.S. and in the Federal Republic of Germany
Development and situation in France
Development and situation in France
Principles of company policy
First company-policy principle
Statutory rulings
Societal consensus
Deficiencies in societal debate
Second company-policy principle
Third company-policy principle
Concluding remarks
Discovery and properties of mifpristone (RU 486)
At the beginning of the 1980s, hormone researchers at the French company
Roussel Uclaf made a discovery that would soon put Roussel Uclaf and its
parent company, HOECHST AG, in media headlines around the world.
Mifepristone as an anti-progesterone
Although the research work absolutely did not originate with the goal of
pregnancy termination in mind, in cooperation with INSERM, the French
National Institute for Health and Medical Research, researchers realized
that the synthetic substance mifepristone (RU 486) is capable of acting in
all reproductive processes against the natural hormone progesterone, which
is necessary to maintain pregnancy.
When pregnancy starts, progesterone ensures that the fertilized egg or
embryo is properly implanted in the endometrium and that the right
conditions are created to make the embryo viable.
Mifepristone occupies the site intended for progesterone in the receptor,
the link between this hormone and the uterus. In this way it blocks
progesterone and prevents it from exerting its effect. That is why
mifepristone is called an anti-progesterone.
[Schematic representation of the mechanisms of action of a hormone and an
anti- hormone]
Combination with prostaglandin
The result is that the endometrium breaks down and the fertilized egg or
the embryo is expelled. This is accelerated by the administration of a
prostaglandin, a substance which induces uterine contractions. The
abortion progresses like a spontaneous miscarriage.
[The action of progesterone in the uterus - schematic]
The action of mifepristone (RU 486) in the uterus
1 initiates breakdown of endometrium
2 detachment of embryo
3 decline in HCG
4 atrophy or corpus luteum
5 decline in progesterone
6 further breakdown of endometrium
7 enhanced contractility of uterine muscle
8 softening and dilation of cervix
9 expulsion of embryo and endometrium
Further application areas
The progesterone-specific blocking action of mifepristone has a number of
further potential uses in gynecology: for instance in facilitating the
induction of labour, therapy for endometriosis (a disorder of the
endometrium) or the treatment of breast cancer and uterine fibroids
(benign tumours).
Clinical studies have not been concluded for the aforementioned
applications. In the meantime, Roussel Uclaf has amassed a wide range of
documentation prepared by numerous gynecological centers concerning the
use of RU 486 in the termination of pregnancy.
The use of mifepristone
Directions for use
Mifepristone is taken in the presence of a doctor, using a dose of 600 mg
(three 200 mg tablets), no later than the 49th day (63rd day in the U.K.)
after the start of the last period. Prior to taking the drug, patients
must be given a week's time for counseling and reflection. 36-48 hours
after the administration of mifepristone, the patient is given a
prostaglandin analogue (a gemeprost vaginal suppository or misoprostol
tablets) which helps with complete expulsion. A check-up is performed 8-12
days later.
Success rate
The use of mifepristone (trademark: Mifegyne) and prostaglandin is amply
documented in France. The data indicate that of approx. 16,000 patients
treated in 300 clinics, expulsion was complete in more than 95% of the
cases, while additional vacuum aspiration was needed in the remaining
cases owing to incomplete abortion (2.8%), continued pregnancy (1.2%) or
heavy bleeding (0.6%).
Responsibility of the manufacturer
Mifepristone - a sensitive product
HOECHST and Roussel Uclaf are and always have been aware of the fact that
mifepristone represents a product that cannot meet with the unanimous
approval of society at home and abroad owing to its use in the termination
of pregnancy.
Market and responsibility
As a leading international business enterprise, HOECHST is intrinsically
involved in many different economic, cultural and political systems. Just
as diverse are people's expectations of what the company should and should
not be providing. Demand varies from country to country and even within a
country itself.
Market supply and demand usually regulate themselves within the legal
framework laid down by the state. This is true unless, despite statutory
rulings, controversial basic interests of humans are affected which do not
result in societal consensus as to whether a certain product is desirable
or not. This puts the market under strain, affected as it then often is
by the po1arized situation; the supplier's reaction to such a scenario
must be one of caution and responsibility.
The legal controversy
HOECHST and Roussel Uclaf still find themselves in a similar situation in
many countries - and particularly subject to close scrutiny in the U.S.
and Germany.
The legal situation in the U.S. and in the Federal Republic of Germany
In both of these countries, the statutory rulings on pregnancy termination
have been the subject of heated debate for some time now. Incidentally,
clear attempts to tighten the criminal law provisions are still
recognizable in both countries.
Polarization in the U.S.
On June 29 1992, the U.S. Supreme Court upheld its decision by a 5:4
majority in Roe vs. Wade, the 1973 ruling that recognized the
unconditional right to abortion. The reason for the review was a
Pennsylvania law that seemed to contradict the 1973 ruling because it made
abortion subject to the fulfillment of certain criteria. Despite the legal
restrictions (counseling by a doctor, a 24-hour reflection period,
permission of at least one parent when minors are concerned), the Supreme
Court did not see a violation of a woman's constitutional right to an
abortion and only declared unconstitutional the stipulation that a wife
must inform her husband of a planned termination.
In light of this decision, restrictive laws in Utah, Louisiana, Nebraska,
North Dakota, Mississippi and West Virginia will also have to be checked
for their constitutionality. In contrast, as a result of referendums held
in Nevada, Connecticut and Washington, the termination of pregnancy would
have remained legal in these states even if the Supreme Court had
withdrawn the constitutional right to abortion.
Polarization in Germany
Since the Federal Constitutional Court's decision of February 25 1975, the
debate in Germany concerning Article 218 never quieted down completely and
has been heating up ever since the trial of a doctor in Memmingen who
performed abortions on several of his patients. A clear consequence of the
debate was the voidance petition of the government of the state of Bavaria
to the Constitutional Court, the outcome of which still has not been
decided.
The petition is primarily based on the rulings of the previous Articles
218b, 219 of the German Penal Code concerning counseling and the
determination of indications for pregnancy termination. Both rulings are
believed to be unconstitutional because they presumably do not
sufficiently fulfill the constitutional requirement to protect the unborn.
The so-called social indication, with which well over 80 percent of the
pregnancy terminations were justified, are said to have virtually become a
substitute reason for allowing abortions during the first three months of
pregnancy, something that is neither legally founded nor constitutional .
These questions were raised again in the debate concerning the reform of
Article 218, which had become more urgent as a result of the reunification
of Germany. Pursuant to the unification treaty of October 3 l990, the
legislator was called upon to harmonize the different laws on abortion in
eastern and western Germany (social and medical indications in the west
and abortion on demand in the east during the first three months of
pregnancy) by the end of 1992. In so doing, the weaknesses of both laws
would be eliminated.
On June 25 1992, a Bundestag majority, or in this case 355
parliamentarians, voted in favour of the so-called group proposal
(abortion during the first three months with mandatory counseling). Two
weeks later, the Bundesrat also approved the bill. After the federal
chancellor (and several cabinet ministers) had countersigned the bill, the
federal president executed the piece of legislation and arranged for its
promulgation in the Federal Law
Gazette. On August 4 1992, the Federal Constitutional Court approved a
petition filed by 248 CDU/CSU parliamentarians and the Bavarian government
for a temporary injunction and unanimously agreed to stop the law
temporarily from taking effect. The definitive future status of Article
218 will not be available until the outcome of the voidance petition
expected for this year is final.
Development and situation in France
The introduction of mifepristone in France
The public debates in recent years that have sometimes been bitter and
irreconcilable became even more intense when Roussel Uclaf (Paris) made
mifepristone available at the end of 1988 after being urged by the French
minister of health, who asserted that it was in the interests of public
health. Faced with a split in public opinion, Roussel Uclaf initially
announced that it did not wish to use its license for the drug, which had
already been granted.
Strict distribution regulations in France
In France, the termination of pregnancy is undertaken only in special
clinics authorized by the state. This also applies to medical termination
with mifepristone, for which special regulations were issued governing
distribution and use. The authorities and Roussel Uclaf jointly control
the distribution of the drug, while the doctors and pharmacists in the
clinics inform the patients about it, obtain their consent, and prescribe
and administer the drug under carefully controlled conditions in each
individual case. Distribution of the drug by pharmacies to the public or
prescription by physicians in private practice are ruled out.
In the meantime, more than 80,000 women in France have opted for
drug-induced termination of pregnancy within the existing legal framework
rather than for the surgical method of termination. However, there is no
evidence that the total number of terminations has increased since 1988.
Medical advantages
The decisive medical advantage of mifepristone lies in the fact that the
health risks and the technological effort and expense associated with
surgical intervention can be avoided. Included among the health risks are
not only the
anesthetic, but also, and in particular, the risks of incomplete
curettage, perforation of the uterine wall, infection and other
complications that can later lead to infertility. Furthermore,
mifepristone can also be used at an early stage of the nidation process.
Clinical experience
The clinical experience accumulated so far shows that no grave risks occur
if the procedure laid down is strictly adhered to. In April 1990, a
patient died in France during pregnancy termination with mifepristone and
prostaglandin. As investigations showed, the ban on treatment of heavy
smokers was not adhered to. Since then, only women who are not older than
35 and haven't smoked in two years may receive the treatment in France. To
date, there have been no observations of negative consequences in
subsequent pregnancies. In all the cases known to date, women treated with
mifepristone who later became pregnant again have given birth to healthy
babies.
Psychological effects
A study about the psychological acceptance of mifepristone has been in
progress in France for some time now. The final results are not available
yet. According to the preliminary survey results, most women viewed the
medical alternative positively. Approximately 30 to 35 percent of the
French women seeking an abortion decided in favour of mifepristone.
Principles of company policy
Three reasons for a special approach
In contrast to conventional drugs for which approval is applied for
directly from the competent authorities after successful clinical testing
in accordance with the legally stipulated practice, HOECHST and Roussel
Uclaf deliberately selected another route.
This was done for three reasons:
o In the eyes of the public, the medical indication of pregnancy
termination does not represent a simple illness like any other for which
the patient is given a prescription in order to recover.
o The statutory rulings on pregnancy termination are in a state of public
controversy despite (or precisely due to) the existing laws and
regulations, judicial and legislative decisions in numerous countries
(e.g. Germany, the U.S., Poland, Ireland).
o The decision to interrupt pregnancy is lastly a matter of conscience,
which - more or less consciously - touches upon the fundamental
ethical-cultural attitudes of pregnant women and society.
Product responsibility
A company that were to disregard these three special reasons when
introducing a sensitive product would not do justice to its circumspection
of and responsibility towards its own economic commitments, the legal
framework of the state and the moral-cultural attitudes of society.
Furthermore, HOECHST and Roussel Uclaf cannot allow themselves to be
influenced by individual people or groups who do not view the reasons
given as components of a complex and integral relationship.
Principles
HOECHST and Roussel Uclaf have therefore jointly laid down the following
company policy on the use of mifepristone (in conjunction with
prostaglandin):
Principle no. 1:
o The registration of mifepristone for the drug-induced termination of
pregnancy can only be applied for in countries that have a definitive
statutory ruling on abortion and where pregnancy termination is tolerated
by society.
Principle no. 2:
o The country in question must have an advanced medical infrastructure.
This must include the availability of prostaglandin and strictly
controlled distribution and use of mifepristone.
Principle no. 3:
o There must be an actual wish for the licensing of mifepristone from a
representative competent body of a particular country.
First company-policy principle
Two preconditions: Statutory ruling and societal consensus
The first company-policy principle contains both of the most important
preconditions for the licensing of mifepristone in a country:
- a definitive statutory ruling on abortion and
- a societal consensus concerning pregnancy termination.
Inherent relationship of both preconditions
The lively public discussions, whether about the reform of Article 218 in
Germany, the U.S. Supreme Court decision or the case of the young girl in
Ireland who was raped, make it clear that both aspects are closely
connected to each other. Even if a statutory ruling on abortion has been
made in accordance with democratic principles, that ruling will not stand
on firm ground if there is no societal consensus on dealing with pregnancy
termination. The ongoing clashes in the U.S. even after the Supreme Court
ruling, the continued polarized debate in Germany after the Bundestag
decision, as wall as the move to the Federal Constitutional Court in
Karlsruhe, Germany are evidence of this.
Statutory rulings
Summary of global statistics
It would now be useful to present a general summary of international
statutory rulings. An evaluation of 144 countries shows the following
picture.
- About one billion people (roughly 20% of the world's population) live in
49 countries where pregnancy can be terminated only if the mother's life
is in danger (e.g. Islamic countries, Latin America, Africa) or where
abortion is illegal under any circumstances (Ireland).
- About 600 million people (some 11% of the world's population) live in 47
countries where the termination of pregnancy is allowed if the mother's
health is at risk, if the foetus has a malformation (embryo pathological
indication) or if the pregnancy is the result of a criminal act.
- About 1.3 billion people (around 25% of the total) live in 23 countries
where pregnancies can also be terminated for social and economic reasons.
- About 2 billion people (roughly 39% of the total) live in countries
where pregnancies can be terminated on request during the first three
months after conception.
- All told, 3.3 billion people (some 64% of the world's population) live
in countries where pregnancies can also be terminated for social and or
economic reasons.
- According to estimates by the World Health Organization, about 40-60
million pregnancies are terminated worldwide every year, of which up to 25
million are carried out illegally; approximately 200,000 women die of the
consequences of (mainly illegal) abortions.
Limited use of statistics
Undoubtedly, this kind of an evaluation is not very powerful because it
reveals very little about the actual motives and behaviour of those
involved. There are for instance countries in which the medical indication
is interpreted so widely that room is even found for the social
indication, with grounds possibly being based on psychosomatic factors
used to define health.
Apart from other reasons, the avoidance of illegal abortions with
uncontrollable deaths of pregnant women in numerous countries has been the
primary reason for decriminalizing and expanding the indications to the
inclusion of abortion any time during the first three months.
Statutory rulings in Germany
In accordance with the unity treaty and until the enactment of a new law,
unified Germany will temporarily (until the end of 1992) have two abortion
laws: one permitting abortion for social or medical reasons in western
Germany and the other legalizing abortion during the first three months of
pregnancy in eastern Germany. The decisive factor is where the abortion
takes place and not where the woman lives.
In view of HOECHST's first principle regarding the registration
application for mifepristone, politicians often suggested that the company
apply for the registration of mifepristone even before the Bundestag had
reached its decision. The reason cited was the existence of a definitive
statutory ruling on abortion.
Two important points were overlooked here. Firstly, by no means did the
unity treaty approve the law of the former GDR but tolerated it at most.
Secondly, a statutory ruling alone does not fulfill HOECHST's requirement
of societal consensus, something that still does not exist today.
Societal consensus
Had Roussel Uclaf applied for a license in these circumstances, this would
have merely intensified the polarization of the argument owing to previous
experiences instead of promoting a discussion aimed at a consensus.
Consensus without ethical behavioural norms - impossible
This is primarily because the two sides of the public debate hold very
different views about the advantages and drawbacks of mifepristone. For
example, while one side is pleased that mifepristone turns abortion into a
workaday occurrence from the medical point of view, the other deplores
this same aspect on the grounds that it is yet another step taken against
the protection of life and that it thus trivializes the termination of
pregnancy.
The same facts are interpreted so differently because the current legal
position is not perceived in the same way by people holding basically
different ethical views. Nationwide consensus can therefore only be
reached at the level of the ethical-cultural issue involved. This proves
that laws do not merely hold because they are laws. Very different norms
can be incorporated into positive law and then declared binding.
Contentious principles of positive law can therefore be clarified and made
known to the public only if basic ethical and cultural foundations are
included in the deliberations. The current public debate on the
termination of pregnancy indicates the difficulties involved in weighing
up laws and morals and still bears the traits of an irreconcilable
conflict.
Deficiencies in societal debate [sic]
Societal debate through differentiation
A clear symptom of the disastrous state of societal debate is the
continuous changing and blurring of the discussion levels.
There are three levels in every society and every social system that are
responsible for the development of the particular system:
o the normative level
o the organizational control level
o the operative level which must meet the needs and objectives of the
system.
Consequently, every country has a cultural system, a political system and
a supply system, which in the broadest sense can be called an economy.
Autonomy and interdependence of the systems
On the one hand, the so-called subsystems of a society, namely culture,
political organization and economy, each have their own specific
structures and output potential while on the other hand they are highly
interdependent.
Autonomy of culture, politics and economy
In the context of the abortion debate (medical as well as surgical), this
means the following:
o the cultural system in the broadest sense (churches, education, culture,
art and the media) is concerned with the empirical and normative questions
of pregnancy termination with the aim of developing acceptable behavioural
norms and promulgating these throughout society.
o the political system of the state provides for the appropriate legal
framework conditions for the adherence to behavioural norms. It ultimately
aims at the stepwise elimination of deficiencies in the subjective outlook
towards and objective aspects of pregnancy termination, yet seeks to stop
negative developments immediately.
o the supply system (the economy including all commercial and non-profit
manufacturing and service organizations) must meet needs of the society
for products and services that conform to the existing legal and cultural
framework conditions applicable to pregnancy termination.
Mutual dependencies of culture, politics and the economy
At the same time however, there are additional ties, dependencies and
responsibilities that exist between the three subsystems of society, i.e.
culture, the state and the economy, which must also be considered in the
abortion debate.
o The cultural system relies on the state for its existence guarantee as
well as on the non-material and material output of the economy in order to
give adequate meaning to its constituent elements
o The ideologically neutral democratic state can only perform its function
of maintaining order within the context of prevailing moral values and
acceptable behavioural norms - thus, it is dependent on the actual output
of the cultural system. By the same token, the democratic state is also
dependent on the prosperity of the economy in order to fulfill its
function of maintaining order.
o And finally, the economy needs sensible and beneficial national policy
conditions as well as a viable cultural system because employees,
customers and their motivations are its often neglected resources.
Polarization in the absence of differentiation ability
These explanations make it clear how easy it is for conflicts and
polarized situations to arise when the autonomy of culture, politics and
economy and their mutual dependencies are mixed together, for example when
traditional and basic moral- cultural convictions are no longer accepted
by large numbers in society but the political and economic system must
continue to function. Societal debate inevitably suffers under the tension
between the social subsystems, as we are experiencing in the abortion
debate and particularly as regards the drug-induced termination of
pregnancy with mifepristone.
New laws, whether Article 218 et seq in the Federal Republic of Germany or
the Supreme Court decision in the U.S. are therefore a necessary but not
the only precondition for the introduction of mifepristone by Roussel
Uclaf. A publicly recognizable societal consensus, and thus one also
recognizable to HOECHST, is an indispensable requirement, one that is also
stated in the first principle of company policy.
Second company-policy principle
As regards the second company-policy principle concerning the use of
mifepristone in connection with a prostaglandin, we'd like to say the
following:
Preventing misuse:
With a preparation as sensitive as mifepristone, the legal standpoint must
not only address the medical and psychological benefits, but also
guarantee the exclusion of illegal and/or improper use. Both forms of
misuse can be avoided if a country has a developed medical infrastructure
and regulations stipulating distribution, administration and control as
found in France and Great Britain.
Third company-policy principle
Responsibility throughout society
The third company-policy principle, which emphasizes the registration
application for mifepristone only when expressly desired by a
representative body of a country, becomes understandable in light of the
complex and existential social problems of pregnancy termination. HOECHST
and Roussel Uclaf can indeed be held accountable in product liability
matters, but social responsibility is something that is shared.
Status in France, the U.K. and Sweden
For HOECHST and Roussel Uclaf, the three requirements of our company
policy have teen fulfilled in France, the U.K. and Sweden.
Roussel Uclaf applied to the Department of Health for a license for
mifepristone in the U.K. at the request of the Royal College of
Obstetricians and Gynecologists. Mifepristone was licensed in the U.R. in
July, 1991 and has been in use only in special centers as in France.
In Sweden, the registration of mifepristone was applied for in December,
1991.
Concluding remarks
Some fundamental considerations in conclusion of this information:
Complexity of cultural and religious traditions
The fact that millions of abortions have been carried out throughout the
history of mankind continually shakes the very foundations of our
self-perception. All religions, cultures and social orders have given the
problem serious thought one way or another, and their different concepts
of man and of the world have led to different judgments and behavioural
norms, which are reflected in the plurality of opinions and regulations we
have today.
The concept of abortion calls for objectivity against the background of
the overall complex structure of interrelationships between the wide
variety of religious traditions, progress shaped by scientific and
technical considerations and by ecological awareness and vast differences
in living standards. Thus, a quarter of the world's population enjoys
economic prosperity while in the rest of the world millions are dying from
starvation and countless others live in abject poverty. Enlightened
awareness of democratic rights stands side by side with widespread
pre-democratic and unenlightened social structures.
An appeal to thinking in terms of complex relationships
There are no easy solutions here. Those who believe in them because they
hold simplistic views of the world, possibly for fundamentalist reasons,
are not behaving responsibly. Those wishing to claim credibility for
themselves in the ethical and legal debate must respect the complexities
of the aforementioned interacting factors - not just in terms of their
historical dimension but also in terms of their interdisciplinary
ramifications.
National and global responsibility
An advanced civilization upholds the indivisible right to life as much as
it respects women and mothers and their moral decisions. In their unique
symbiosis, both are however threatened today in equal measure by an
existing materialistic, individualistic and hedonistic attitude towards
life. In this situation, society is obliged to respect women and their
decisions. And should a woman decide not to carry a child to term,
outsiders should always assume the hopelessness and severity of the
situation until the opposite is proven.
Social responsibility for life must prevail wherever human life and the
dignity of human life are threatened. It is all too easy to allow local
concerns to overshadow global challenges if we fail to escape from the
traditional confinement of the here and now in our ethical orientation.
This is where churches operating around the world are called upon as
advocates of life.
There have been too many speeches but still too little has been said in
the public abortion debate so far. This must change if society is to
arrive at an agreement over and above the democratic vote of the majority.
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